Recall Z-2281-2023— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2023-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323. Reason: A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis.
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-06-29
- Firm location
- Danvers, MA, United States
Product description
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Reason for recall
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
Data sourced from openFDA. This site is unofficial and independent of the FDA.